“Brand Name or Equal” Millipore-Sigma Steritest Symbio Laminar Flow Hood (LFH) pump

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is 75F40126Q135530. This solicitation is issued as a Request for Quote (RFQ). The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1000 employees. This requirement is solicited for full and open competition. Schedule of Items (all shipping and handling shall be included in the price) Item # Description Quantity Unit Unit Price Extended Price 1 “Brand Name or Equal” Millipore-Sigma Steritest Symbio Laminar Flow Hood (LFH) pump 1 Each $_________ $___________ Grand Total: $______________ Statement of Work: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) Division of Biological Standards and Quality Control (DBSQC), is a regulatory testing laboratory that is ISO 17025 accredited. The laboratory is responsible for microbiological testing of multiple biological drugs and reagents, which require sterility testing to determine if they comply with regulations. The laboratory performs sterility testing using Steritest ISL pumps manufactured by Millipore-Sigma. In order to remove existing bottlenecks in suitability testing which precedes sterility testing, the laboratory requires an additional closed-filtration sterility pump that is a “Brand Name or Equal” Millipore-Sigma Steritest Symbio Laminar Flow Hood (LFH) pump, to be used in a laminar air flow hood. The acquisition of a “Brand Name or Equal” Millipore-Sigma Steritest LFH pump will ensure compatibility with existing Millipore-Sigma Steritest ISL test kits used by the laboratory for sterility testing, allowing their continued use with the new closed-filtration pump and enabling the laboratory to meet the suitability requirements specified in USP <71>, the official compendial method for sterility testing. This is a Brand Name or Equal requirement. Products other than the specified Millipore-Sigma Steritest Symbio LFH pump are acceptable but shall meet all the salient characteristics contained in the Minimum Technical Requirements below. Minimum Technical Requirements (Salient Characteristics): 1. The instrument shall consist of a peristaltic pump compatible with Steritest membrane filtration canister devices. -- 1 of 14 -- 2. The pump shall have a compact design to be used in a 6-foot biosafety cabinet or a laminar flow hood. 3. The pump shall be equipped with a pump head capable of automatic opening and closing during operation. The pump housing is to be constructed of 316L stainless steel. 4. The pump housing and components to be resistant to vaporized hydrogen peroxide gas. 5. The peristaltic pump shall have adjustable speed control with a maximum speed of at least 200 rpm. 6. The pump shall be equipped with an integrated pressure monitoring system to detect abnormal filtration conditions. 7. The pump shall include a pressure regulation or limiting function to protect membrane integrity. 8. The pump shall be equipped with a user interface capable of configuring instrument settings and displaying operating status. 9. The interface shall include a display screen capable of presenting operating parameters and alerts. 10. The pump shall be equipped with a timer function. 11. The pump shall have the ability to store at least 50 filtration protocols. 12. The pump shall be compatible with Millipore-Sigma, Steritest Symbio ISL Pump, Serial # LFH170. Qualification (IQ/OQ/PQ) Requirements: 1. Provide qualification protocol for FDA review and address any comments / suggestions 2. Execute qualification based on FDA approved protocol 3. Use calibrators with current ATCC/NIST traceable calibration 4. Confirm manufacturer’s specifications 5. Prepare qualification report with data and any deviations 6. Provide qualification report for FDA review and address any comments / suggestions. Installation, Training and Additional System Requirements: 1. The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. 2. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. 3. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. 4. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format. -- 2 of 14 -- 5. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures. 6. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts. Phone and email technical support shall be included for a minimum of one (1) year. Place of Delivery: FOB Point Destination. All items shall include shippi…